Corporate Banner
Satellite Banner
Molecular & Clinical Diagnostics
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

Alere to Develop Simple, Affordable Point-of-Care Nucleic Acid Test for Tuberculosis

Published: Tuesday, March 05, 2013
Last Updated: Tuesday, March 05, 2013
Bookmark and Share
Alere Inc. announced that it has been awarded a grant of up to $21.6 million and debt financing of up to $20.6 million from the Bill & Melinda Gates Foundation.

The $21.6 million grant will fund the development of a tuberculosis assay, which will be designed for use in both resource-constrained and well-resourced settings. It will also support the company’s efforts to incorporate one of its isothermal amplification technologies for TB detection onto the Alere™ Q, a compact, portable, and robust device intended for molecular testing at the point of care. In addition, the Gates Foundation will provide below-market loans of up to $20.6 million for the expansion and scale up of Alere’s manufacturing facilities in Jena, Germany for both the POC TB Nucleic Acid Test and the POC HIV Viral Load Test currently in the final stages of development. The Gates Foundation will provide these loans in exchange for commitments from Alere to make these diagnostics available at an affordable price to people in need in developing countries.

Tuberculosis is a leading cause of death worldwide, and nearly 8.8 million cases of TB occur each year, mostly in middle-income and low-income countries. Today, laboratory-based technologies provide the primary means for diagnosing the illness, but these technologies often fail to identify large numbers of active cases, take weeks to deliver results, lack crucial drug resistance information, or are unable to meet the needs of individuals with limited access to lab facilities. Alere’s collaboration with the Gates Foundation will produce a highly sensitive, low-cost diagnostic that can be implemented in lower-level laboratories or outside the lab altogether.

A world leader in near-patient diagnostics, Alere is committed to developing solutions that support screening for the world’s most burdensome diseases, such as TB and HIV, and support the ongoing monitoring of people living with HIV or HIV-related conditions like TB.

Alere will deploy a previously acquired isothermal amplification technology for TB detection and is developing a molecular device, the AlereTM Q, which is currently in clinical trials, to support near-patient molecular testing for HIV. Merging these technologies in a single platform will play an invaluable role in combating the TB epidemic. The platform will offer the high-performance sensitivity and specificity needed to diagnose individuals with TB accurately. Moreover, it may be used for strain and antibiotic resistance typing at the point of care, which should ultimately serve to improve patient management and fight the spread of drug-resistant strains. Compact design, battery-powered portability, and ease of use will make the AlereTM Q ideal for even the most basic healthcare settings.

Furthermore, Alere’s highly automated manufacturing processes will ensure that both the instrument platform and consumables can be produced at an accessible price that enables widespread adoption. Since the introduction of its revolutionary Alere™ CD4 product in 2010, Alere has built the manufacturing site in Jena, Germany, into a center of excellence for instrument-based, point-of-care diagnostics. As part of the agreement, HIV test manufacturing will be fully automated and scaled to the level needed to make the product globally accessible.

Commenting on the award, Alere CEO Ron Zwanziger said, “Providing affordable products that transform the way medicine is practiced, especially in resource-limited settings, is part of Alere’s heritage. There is a critical need for near-patient diagnostics that accurately identify TB cases and facilitate effective management to keep the condition under control. We are very excited to have the support of the Gates Foundation in fighting one of the most dangerous infectious diseases, and we remain committed to providing solutions that improve health outcomes for individuals living with HIV.”

“Although significant progress has been made in combating tuberculosis over the past 25 years, it remains one of the leading causes of death worldwide. To provide earlier treatment and prevent the spread of TB, we need fast, accurate diagnostic tools that can be easily implemented in resource-limited environments,” said Bill Gates, co-chair of the Bill & Melinda Gates Foundation. “Alere has a track record of diagnostic innovation and leveraging cost-effective technologies to improve health outcomes for individuals living with HIV in the most remote parts of the world. The Gates Foundation has put its support behind the company to apply these same principles in addressing the TB epidemic and potentially saving millions of lives.”

Development on the TB assay has commenced, and validation for its use is expected within the next 24 months.


Further Information
Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 2,500+ scientific posters on ePosters
  • More than 3,700+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.


Scientific News
The Changing Tides of the In Vitro Diagnostics Market
With the increasing focus in personalized medicine, diagnostics plays a crucial role in patient monitoring.
Poor Survival Rates in Leukemia Linked to Persistent Genetic Mutations
For patients with an often-deadly form of leukemia, new research suggests that lingering cancer-related mutations – detected after initial treatment with chemotherapy – are associated with an increased risk of relapse and poor survival.
'Fountain of Youth' Protein Points to Possible Human Health Benefit
Patients with higher blood levels of growth factor have lower risk of cardiovascular problems.
Signature of Microbiomes Linked to Schizophrenia
Studying microbiomes in throat may help identify causes and treatments of brain disorder.
Imaging Software Could Speed Breast Cancer Diagnosis
Technology could improve access to diagnostic services in developing countries.
Data Mining DNA For Polycystic Ovary Syndrome Genes
A new Northwestern Medicine genome-wide association study of PCOS – the first of its kind to focus on women of European ancestry – has provided important new insights into the underlying biology of the disorder.
Algorithm Interprets Breathing Difficulties to Aid in Medical Care
Researchers from North Carolina State University have developed an efficient algorithm that can interpret the wheezing of patients with breathing difficulties to give medical providers information about what’s happening in the lungs.
Researchers Develop qPCR Prognosis Test for NSCLC Patients
A nine-gene molecular prognostic index (MPI) for patients with early-stage non-small cell lung cancer (NSCLC) was able to provide accurate survival stratification and could potentially inform the use of adjuvant therapy in patients struggling with the disease.
Genetic Test Could Improve Blood Cancer Treatment
Testing for genetic risk factors could improve treatment for myeloma – a cancer of the blood and bone marrow – by helping doctors identify patients at risk of developing more aggressive disease.
PTR-MS Breath Test Shows Potential for Detecting Liver Disease
Researchers at the University of Birmingham have published results that suggest a non-invasive breath test for liver disease using an IONICON PTR-MS.
Skyscraper Banner

Skyscraper Banner
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
2,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,700+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FREE!